Trial Outcomes & Findings for Surveillance for Adverse Events Following Influenza Immunization (NCT NCT01318876)

NCT ID: NCT01318876

Last Updated: 2012-08-21

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 7645 participants
• Primary outcome timeframe: at day 8 and 29
• Results posted on: 2012-08-21

Participant Flow

Participant milestones

Measure	Health Care Workers
Day 8 Survey STARTED	7645
Day 8 Survey COMPLETED	5825
Day 8 Survey NOT COMPLETED	1820
Day 29 Survey STARTED	7549
Day 29 Survey COMPLETED	5724
Day 29 Survey NOT COMPLETED	1825

Reasons for withdrawal

Measure	Health Care Workers
Day 8 Survey email address invalid	96
Day 8 Survey survey not completed-don't know why	1724
Day 29 Survey survey not completed-don't know why	1825

Baseline Characteristics

Surveillance for Adverse Events Following Influenza Immunization

Baseline characteristics by cohort

Measure	Health Care Workers n=6269 Participants HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6269 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	41.77 years STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	4639 Participants n=5 Participants
Sex: Female, Male Male	1630 Participants n=5 Participants

PRIMARY outcome

Timeframe: at day 8 and 29

Outcome measures

Measure	HCW From All Sites n=6269 Participants
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation	153 participants

PRIMARY outcome

Timeframe: day 8 and 29

Outcome measures

Measure	HCW From All Sites n=6269 Participants
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.	254 participants

Adverse Events

HCW From All Sites

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HCW From All Sites n=6269 participants at risk
Vascular disorders Spontaneous intracranial hypotension	0.02% 1/6269 • Number of events 1
Renal and urinary disorders kidney stone	0.02% 1/6269 • Number of events 1
Reproductive system and breast disorders uterine fibroids	0.02% 1/6269 • Number of events 1
Immune system disorders anaphylactic shock to peanuts	0.02% 1/6269 • Number of events 1
Immune system disorders allergic reaction (received epinephrine)	0.02% 1/6269 • Number of events 1
Respiratory, thoracic and mediastinal disorders bilateral pulmonary embolism	0.02% 1/6269 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Gaston De Serres

Laval University

Phone: 418-666-7000

Email: gaston.deserres@ssss.gouv.qc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place